| CTRI Number |
CTRI/2025/05/087884 [Registered on: 29/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of yoga on pelvic floor health on elderly women with prolapse |
|
Scientific Title of Study
|
Effect of yoga on pelvic floor distress and quality of life among elderly women with pelvic organ prolapse: a prospective randomized controlled trial |
| Trial Acronym |
Y-POP trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Mishra |
| Designation |
Medical Officer |
| Affiliation |
AIIMS Rishikesh |
| Address |
AYUSH department, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8965983008 |
| Fax |
|
| Email |
shweta.ayush@aiimsrishikesh.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Sriloy Mohanty |
| Designation |
Senior Medical Officer |
| Affiliation |
AIIMS Rishikesh |
| Address |
AYUSH Department, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9560540977 |
| Fax |
|
| Email |
sriloy.smo.ayush@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sriloy Mohanty |
| Designation |
Senior Medical Officer |
| Affiliation |
AIIMS Rishikesh |
| Address |
AYUSH Department, AIIMS, Rishikesh
UTTARANCHAL
249203
India |
| Phone |
9560540977 |
| Fax |
|
| Email |
sriloy.smo.ayush@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| Intramural trial at AIIMS, Rishikesh, Uttarakhand, 249203. India |
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
AIIMS, Rishikesh, veerabhadra road, Rishikesh , Uttarakhand, India .pin code:249203 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shweta Mishra |
AIIMS Rishikesh |
Building no. 30 , Department of AYUSH
Dehradun
UTTARANCHAL |
8965983008
shweta.ayush@aiimsrishikesh.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N814||Uterovaginal prolapse, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard of care |
The standard of care group will be advised to continue the standard medical care for the same duration, i.e. 3 months including an educational session of risk reduction advice at baseline 4th week and 8th week which includes the need of addition of physical activity to the daily routine, dietary changes, etc. |
| Intervention |
Yoga including loosening exercise, Breathing exercise, asanas, and pranayama |
There will be a minimum of 5 contact classes of 45 minutes each in the 3 months period. There will be three supervised sessions within the first week following the recruitment, following that one session at end of first and second month of the first day of intervention. During non-contact period, the subjects will be advised to practice Yoga everyday at home. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
2. Patients with complaint of mild to moderate grade pelvic organ prolapse
3. Willing to participate |
|
| ExclusionCriteria |
| Details |
1. Severe grade prolapse
2. Patients who have undergone recent pelvic surgeries
3. Patients with malignancy or fibroid
4. Contraindications to yoga and exercise testing
5. Participating in any other trial, giving any additional complementary therapy
6. Participant practicing yoga prior to the recruitment in the study
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pelvic floor distress inventory-20 scores |
baseline, 4th week, 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Health Related Quality of life (HRQL): Prolapse QoL
2. Vaginal perineometer for vaginal squeeze scores
3. Depression Anxiety stress scale (DASS21)
4. Subsets of Pelvic floor distress inventory-20 i.e. colorectal anal distress inventory, urinary distress inventory, pelvic organ prolapses distress inventory.
5. Modified oxford scale and POP Q system to evaluate the degree of prolapse.
|
Baseline and 3 months |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The proposed study design is a parallel, prospective, open labeled, randomized controlled trial with 1:1 allocation ratio. Patients will be randomized into intervention arm and control arm. The study will be conducted in collaboration with three department of AIIMS, Rishikesh i.e. Department of Gynecology, Department of Geriatric and AYUSH. The subjects will be screened and recruited from Gynecology and geriatric medicine. The intervention will be provided at AYUSH department.The aim of the current trial is to evaluate the effectiveness of yoga on reducing prolapse symptoms and quality of life among elderly women with pelvic organ Prolapse. |